GUEST CONTRIBUTORS

  • M&A Technical Due Diligence: The Starting Point For Outsourcing Your New Products
    M&A Technical Due Diligence: The Starting Point For Outsourcing Your New Products

    The past few years have seen a record number of mergers and acquisitions (M&As) in the pharmaceutical industry. When a pharmaceutical company acquires or merges with another pharmaceutical company, there is already in-house expertise on all aspects of the business, and the due diligence is performed by dispatching the document reviews among the different company’s departments, i.e., finance, legal, marketing, regulatory, operations, and logistics.

  • How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included]
    How To Optimize Your Stability Program At Each Phase Of Drug Development [Checklists Included]

    A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.

  • FDA’s Quality Metrics Guidance: Reading Between The Lines
    FDA’s Quality Metrics Guidance: Reading Between The Lines

    One week before we published the article 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance, Life Science Connect attended a thought-provoking presentation about said guidance at a local ISPE event in Philadelphia. While the article covered several key things the guidance document did communicate to industry, the ISPE presentation focused more on what the guidance document failed to say and do … and the implications of those omissions.

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PHARMA OUTSOURCING WHITE PAPERS

Reducing The Burden Of Data Collection In Oncology Trials Reducing The Burden Of Data Collection In Oncology Trials

Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn't easy for patients to report their health data, they won't - so it must be accessible for them.

How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions

The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

The Future of BioManufacturing

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Upgrade Your Chromatography System – 10 Ways To Boost Your Productivity

By upgrading from ÄKTAexplorer to ÄKTA avant chromatography system, you can improve productivity in process development. Depending on your application and how the system is operated, different ways to improve your productivity will have varying impact. Here we show 10 ways to boost your productivity.

Customizing The Cold Chain

With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.

More From OP White Papers - random

PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Automated pH Adjustment In An Intelligent Single-Use Mixing Platform

Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.

Sharing Instruments: Bottleneck Or Increasing Utilization?

Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.

How A Big Pharma Company Quickly Transferred 2 Oral Powder Antibiotics To Another Facility

Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.

Vertex Pharmaceuticals: Document Management Strategies For R&D

Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

INDUSTRY INSIGHTS

  • How Do You Set Up A Quality Pharma Organization?
    How Do You Set Up A Quality Pharma Organization?

    In the pharmaceutical industry, the FDA good manufacturing practices are ever evolving, but the roots are established in 21 CFR Parts 210 & 211 (for drugs). FDA has recently began looking at quality metrics as well, and even established an Office of New Drug Quality Assessment (ONDQA) which assesses the critical quality attributes and manufacturing processes of new drugs.

  • What Are My Options For Reducing My Pharmaceutical Product Manufacturing Costs?
    What Are My Options For Reducing My Pharmaceutical Product Manufacturing Costs?

    In order to set up a quality organization, the organization must have a culture of quality. Survey findings in the Forbes Insights-ASQ white paper published in fall of 2014 offer research findings which help illuminate what quality culture means to organizations globally.

  • What Product-Life Cycle Management Strategies Could Be Used To Extend The Life Of A Pharmaceutical Drug?
    What Product-Life Cycle Management Strategies Could Be Used To Extend The Life Of A Pharmaceutical Drug?

    Name brand (Innovator) pharmaceutical companies must extend the product life cycles of drugs to maintain profits, exclusivity, market share and transition into next generation products. Patent protection is crucial to the innovative pharmaceutical industry. Innovative companies require the guaranteed period of market exclusivity to sustain drug prices, recoup research and development costs and to fund the development of new products or next generation drugs.

  • 5 Key Factors That Contribute To Price Differences Between Tablets And Creams In Drug Manufacturing
    5 Key Factors That Contribute To Price Differences Between Tablets And Creams In Drug Manufacturing

    Pharmaceutical companies frequently ask us this question when they have a multi-dosage form portfolio they want us to provide a quotation or scope of work on. The answer to this question is multi-faceted in that there are a number of questions with regard to materials, process, and testing requirements that need to answered.   

  • How Much Does It Cost To Make A Pharmaceutical Tablet Product?
    How Much Does It Cost To Make A Pharmaceutical Tablet Product?

    Pharmaceutical companies frequently ask us this question: how much does it cost to manufacture a pharmaceutical tablet? The real answer is: it depends on many factors. We need to truly understand the detailed specifics of the pharmaceutical company’s objectives and requirements for the product, with respect to manufacturing, packaging, testing, and regulatory submission in order for us to address cost in an intelligent and realistic manner.

More Industry Insights

OUTSOURCING EVENTS

Cleanroom Microbiology – A Foundational Introduction April 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls May 2, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Data Integrity in a GxP Environment – Top Tips for Compliance May 3, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding and Implementing the New EU Regulation for Initiating and Conducting Clinical Trials May 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response May 9, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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